Clinical trial · Interventional
A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma
A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It is difficult to screening subject
Summary
Brief summary (as posted)
This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Famitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- famitinib
- interventionNames
- Drug: Famitinib
Primary outcomes (1)
- measure
- Objective response rate per RECIST 1.1
- timeFrame
- up to 24 months
Secondary outcomes (6)
- measure
- DOR
- timeFrame
- At pre-defined intervals from initial dose up to 24 months
- description
- Duration of Response
- measure
- DCR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary participation and written informed consent; 2. Aged 18-75 years (inclusive), males and females; 3. Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy; 4. FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory; 5. At least one measurable lesion that has not been treated locally; 6. ECOG score of 0-1; 7. Expected survival ≥ 12 weeks; Exclusion Criteria: 1. Presence of multiple factors affecting oral medications; 2. Wounds unhealed over a long period of time, or fractures not completely healed; 3. Known or suspected allergy to investigational drug or any drug related to this trial. 4. Known cases of CNS(Central Nervous System) metastasis; 5. Uncontrolled cardiac diseases or symptoms; 6. Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants; 7. Patients previously treated with FGFR inhibitors (such as erdafitinib)
References
Publications (0)
Data not yet available